MindMed

Content Writer

• Authors routine clinical and regulatory documents (e.g., clinical study protocols, clinical study reports, investigator's brochures, and sections of regulatory submissions) in partnership with cross-functional team with oversight
• Performs quality checks of documents and data files
• Performs technical edits and formatting of documents, maintains templates, SOPs, Style Guides, and work instructions
• Communicates proactively and efficiently within the MW team and across other functional areas
• Supports clinical study execution through expert review of study-level documents authored by other functions (e.g., study deviations, study manuals, consent forms, analysis plans, data outputs)
• Coordinates and leads document submission workflows (eg, kick-off meetings, roundtables, reviews, quality control (QC) and other content activities, approvals) by managing issues and facilitating resolutions
• Works with project management to develop timelines for documents and communicates with team members to maintain awareness of expectations, milestones, and deliverables
• Collaborates with cross-functional team to review study results
• Contributes scientific knowledge and analytical skills to the production of documents
• Participates in developing key messages for routine documents and conducts literature searches
• Reviews clinical trial registry postings for assigned studies
• Stays current with respect to key global guidance documents, regulations, or directives
• Works effectively with an electronic document management system and related tools to develop clinical documents
• Maintains effective working relationships with contractors, vendors, and partners

Associate Director, Medical Writing

Director

• Direct publication planning and execution, including abstracts, posters, manuscripts, and congress presentations, aligned to company goals and clinical development milestones
• Lead cross-functional publication teams to develop, manage, and implement publication plans
• Liaise with internal & external subject matter experts to ensure high quality analysis, interpretation, and publication of data
• Cultivate cross-functional collaboration among Clinical, Medical Affairs, HEOR, Commercial, and Communications teams to drive unified messaging
• Provide scientific expertise and direction for all publications, including reviewing developed content and ensuring process is consistent with SOPs
• Lead publication committee discussions, including monthly, quarterly, and yearly publication update meetings as needed
• Oversee the activities of external vendors, ensuring high quality of work and adherence to timelines, deadlines, and budgets
• Manage the annual budget and contracting process for all publications
• Work closely with Medical Affairs leadership to incorporate the strategic publication plan into the Medical Affairs framework
• Ensure documentation of compliance with authorship and publication guidelines as stipulated by the International Committee of Medical Journal Editors (ICMJE) and Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP)
• Provide strategic oversight to ensure accuracy, compliance, and alignment of all scientific publications.
• Ensure consistency and alignment across all internal and external communication platforms
• Ensure publications are aligned with scientific narrative and lexicon and strategy, including key strategic communication points and interpretation of statistical analyses
• Maintain thorough and up-to-date knowledge of disease state, clinical information, and product data
• As needed, create education and presentation materials in support of internal and external customer needs ensuring compliance with regulatory and legal guidelines
• Accurate and timely reporting of post-publications metrics
• Experience in congress planning and general Med Affairs operations

Senior Director, Medical Affairs Publications

• Serve as the study lead programmer for assigned clinical trial(s), and work closely with study statistician, data management, and other functions within the study team to provide statistical programming support as needed
• Review and ensure high quality of Define packages including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for assigned clinical trial(s)
• Review and ensure high quality of Define packages for integrated datasets from meeting CDISC standards to meeting regulatory requirements as part of electronic submission
• Work closely with study lead biostatistician to manage vendor’s deliverables from quality to timeline
• Perform independent validation (QC) to ensure accuracy of statistical vendor’s deliverables from datasets to analytic outputs
• Perform independent validation (QC) to ensure accuracy of analytic outputs produced by internal biostatisticians or statistical programmers
• Work closely with Clinical Data Management colleagues to produce systematic data reports to support efficient clinical trial data review and cleaning
• Review CRF and/or Data Transfer Specification to ensure that data collection will meet the study objectives, requirements, and standards in CDISC format
• Provide input to Statistical Analysis Plans and TLF Shells for Tables/Listings/Figures
• Perform statistical analysis to support publications, and/or regulatory correspondence as needed
• Perform other duties as assigned

Associate Director, Statistical Programming

System Administrator

• Work with users across MindMed to analyze and capture stakeholder needs, understand and evaluate relevant technology options, and apply advanced decision-making strategies to develop innovative system solutions
• Maintain user access, roles, and rights, and implement appropriate controls and audits
• Audit systems for compliance with internal and external standards
• Configure and maintain Vault environments, including workflows, document types, lifecycles, and metadata
• Identify and implement process improvements through automation, new features, or configuration change
• Maintain system integrity, including monitoring integrations, scheduled scripts, and system logs
• Assist with Computer Systems Validation activities include development, review and execution of user requirements, validation plans, protocols, and reports
• Monitor system performance and troubleshoot issues to ensure uptime and reliability
• Ensure adherence to GxP, FDA 21 CFR Part 11, and other regulatory requirements
• Train end-users and create documentation for system processes and best practices
• Collaborate with IT and business teams to integrate Veeva Vault with other enterprise systems
• Act as the Veeva Vault SME to evaluate system upgrades, patches, and new feature deployments
• Identify opportunities to optimize workflows and improve user experience
• Stay current with Veeva Vault updates and industry best practices

Senior R&D System Administrator

• Own and lead the global strategy for Expanded Access Programs and Phase 4 development
• Partner with the CMO, Clinical Development, Medical Affairs, Regulatory Affairs, Commercial, Asset Strategy Lead and Program Leadership to ensure EAP and Phase 4 activities are fully integrated into the overall asset strategy and Target Product Profile (TPP)
• Serve as the clinical development lead for governance discussions related to post‑approval and access strategies, clearly articulating risks, trade‑offs, and recommendations
• Design and implement Expanded Access Programs, including protocol development, eligibility criteria, safety oversight, and operational execution
• Lead cross‑functional planning to ensure EAPs are compliant, scalable, ethically sound, and aligned with regulatory guidance
• Provide clinical leadership for benefit–risk assessment, safety monitoring, and ongoing program evaluation
• Define Phase 4 objectives, including real‑world evidence generation, long‑term safety, effectiveness, and differentiation in the treatment landscape
• Lead the design, planning, and execution of Phase 4 studies, including protocol development, data collection strategies, and interpretation of outcomes
• Ensure Phase 4 programs address regulatory commitments, payer needs, and scientific gaps
• Lead preparation and review of clinical content for regulatory submissions and interactions as applicable
• Act as a clinical subject matter expert in interactions with U.S. and ex‑U.S. health authorities related to Expanded Access and Phase 4 activities
• Oversee clinical input into Investigator Brochures, clinical study reports, in collaboration with Regulatory Affairs
• Work collaboratively with Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, and Project Management to ensure high‑quality execution
• Establish and maintain relationships with key investigators, advisors, and external experts to support EAP and Phase 4 objectives
• Provide clinical leadership within matrix teams, modeling accountability, collaboration, and scientific rigor

Associate Director, Medical Writing

Senior Director, Medical Affairs Publications

Associate Director, Statistical Programming

Senior R&D System Administrator

Executive Director – Expanded Access and Phase 4 Clinical Strategy